U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 207925

Expand all

KALYDECO (IVACAFTOR)
5.8MG/PACKET
Marketing Status: Prescription
Active Ingredient: IVACAFTOR
Proprietary Name: KALYDECO
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 5.8MG/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207925
Product Number: 004
Approval Date: May 3, 2023
Applicant Holder Full Name: VERTEX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
KALYDECO (IVACAFTOR)
13.4MG/PACKET
Marketing Status: Prescription
Active Ingredient: IVACAFTOR
Proprietary Name: KALYDECO
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 13.4MG/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207925
Product Number: 005
Approval Date: May 3, 2023
Applicant Holder Full Name: VERTEX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
KALYDECO (IVACAFTOR)
25MG/PACKET
Marketing Status: Prescription
Active Ingredient: IVACAFTOR
Proprietary Name: KALYDECO
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 25MG/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207925
Product Number: 003
Approval Date: Apr 29, 2019
Applicant Holder Full Name: VERTEX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
KALYDECO (IVACAFTOR)
50MG/PACKET
Marketing Status: Prescription
Active Ingredient: IVACAFTOR
Proprietary Name: KALYDECO
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 50MG/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207925
Product Number: 001
Approval Date: Mar 17, 2015
Applicant Holder Full Name: VERTEX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
KALYDECO (IVACAFTOR)
75MG/PACKET
Marketing Status: Prescription
Active Ingredient: IVACAFTOR
Proprietary Name: KALYDECO
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 75MG/PACKET
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207925
Product Number: 002
Approval Date: Mar 17, 2015
Applicant Holder Full Name: VERTEX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top